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510(k) K193530

Deklene MAXX by Teleflex Medical — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2020
Date Received
December 20, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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